Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, I...
FDA Recall #Z-0992-2025 — Class I — December 31, 2024
Product Description
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Reason for Recall
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
58 kits
Distribution
US Nationwide.
Code Information
1) ART600 UDI-DI: 10653160312727 (each), 00653160312720 (case), Lot Number 2024110190; 2) ART690 UDI-DI: 10653160318019 (each), 00653160318012 (case), Lot Number 2024092490
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated